FDAClass IIIJanuary 19, 2022

Ki Mobility recall

Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for…

Why was Ki Mobility recalled?

The Instructions for Use provided with the device contained information intended for use of a mechanical wheelchair, not a chair with casters.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No.: TYK; Serial No: TYK0000500, TYK0000501, TYK0000502, TYK0000503, TYK0000504, TYK0000506, TYK0000505, TYK0000507, TYK0000508, TYK0000509, TYK0000510, TYK0000512, TYK0000511, TYK0000513, TYK0000517, TYK0000520, TYK0000518, TYK0000514, TYK0000515, TYK0000519, TYK0000516, TYK0000521, TYK0000522, TYK0000525, TYK0000524, TYK0000526, TYK0000527, TYK0000528, TYK0000530, TYK0000529, TYK0000531, TYK0000532, TYK0000534; UDI: (01)00850013379231(11)2021-04-05(21)TYK0000500, (01)00850013379231(11)2021-04-12(21)TYK0000501, (01)00850013379231(11)2021-04-13(21)TYK0000502, (01)00850013379231(11)2021-04-19(21)TYK0000503, (01)00850013379231(11)2021-04-29(21)TYK0000504, (01)00850013379231(11)2021-06-11(21)TYK0000505, (01)00850013379231(11)2021-06-11(21)TYK0000507, (01)00850013379231(11)2021-06-11(21)TYK0000508, (01)00850013379231(11)2021-07-08(21)TYK0000509,(01)00850013379231(11)2021-07-08(21)TYK0000510, (01)00850013379231(11)2021-06-11(21)TYK0000512, (01)00850013379231(11)2021-07-14(21)TYK0000511, (01)00850013379231(11)2021-08-06(21)TYK0000513, (01)00850013379231(11)2021-08-06(21)TYK0000517, (01)00850013379231(11)2021-08-06(21)TYK0000520, (01)00850013379231(11)2021-08-06(21)TYK0000518, (01)00850013379231(11)2021-08-06(21)TYK0000514, (01)00850013379231(11)2021-08-06(21)TYK0000515, (01)00850013379231(11)2021-08-06(21)TYK0000519, (01)00850013379231(11)2021-08-06(21)TYK0000516, (01)00850013379231(11)2021-08-16(21)TYK0000521, (01)00850013379231(11)2021-09-02(21)TYK0000522, (01)00850013379231(11)2021-09-20(21)TYK0000525, (01)00850013379231(11)2021-09-20(21)TYK0000524, (01)00850013379231(11)2021-10-04(21)TYK0000526, (01)00850013379231(11)2021-10-04(21)TYK0000527, (01)00850013379231(11)2021-10-12(21)TYK0000528, (01)00850013379231(11)2021-10-29(21)TYK0000530, (01)00850013379231(11)2021-10-29(21)TYK0000529, (01)00850013379231(11)2021-11-16(21)TYK0000531, (01)00850013379231(11)2021-11-17(21)TYK0000532, (01)00850013379231(11)2021-11-17(21)TYK0000534.

Product
Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for…
Recalling firm
Ki Mobility Llc
Quantity
33 units shipped with affected manuals
Distribution
Domestic: IL, IN, KY, MI, MO, NC, SC, and TN.
Recall date
January 19, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls